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Scaling up an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam: an Implementation Trial (SNaPR01)

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ClinicalTrials.gov Identifier: NCT03952520
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Ohio State University
Johns Hopkins University
Hanoi Medical University
Vietnam Administration for HIV/AIDS Control (VAAC)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The purpose of this study is to compare two implementation approaches [standard Intervention Mapping (IM) vs. tailored Intervention Mapping (TIM)] for scaling-up the evidence-based systems navigation and psychosocial counseling integrated intervention (SNaP) in HIV test sites in Vietnam.

Condition or disease Intervention/treatment Phase
HIV Infections Drug Use Other: Standard Intervention Mapping (IM) Other: Tailored Intervention Mapping (TIM) Not Applicable

Detailed Description:

This is a cluster randomized, controlled implementation trial to compare two implementation approaches for scaling-up the SNaP intervention in 42 HIV test sites in Vietnam, considering effectiveness, cost, and the characteristics of HIV test sites who achieve successful or unsuccessful implementation of SNaP.

The two implementation approaches being compared are:

  • standard, one-size-fits-all Intervention Mapping (IM); vs.
  • tailored Intervention Mapping (TIM)

SNaP is an evidence-based intervention (EBI) that combines systems navigation and psychosocial counseling to facilitate the engagement of HIV-infected people who inject drugs (PWID) into HIV and substance use care. Intervention Mapping is a formalized multistep process incorporating theory, evidence, and stakeholder perspectives to select a package of implementation strategies that addresses barriers to implementation of EBI such as SNaP, and it can be extended to tailor implementation strategies to specific contexts.

The 42 HIV test sites will be randomized in a 1:1 ratio to either the IM arm or TIM arm.

At the HIV test sites, the study will enroll:

  • Approximately 6200 HIV-infected PWID who are newly diagnosed and not currently on antiretroviral therapy (ART), who consent for medical record assessments. Of those PWID enrolled, a subsample cohort of 1500 PWID will also be enrolled for detailed assessments, including viral load determination, at baseline, 12 and 24 months.
  • HIV test site director boards and staff.

Study activities will span across 5 years, with approximately 27 months at each site and recruitment of PWID participants over 21 months. For PWID not in the subsample cohort, participation is a one-time visit. For the subsample cohort PWID or PWID selected for qualitative interviews, maximum study participation time is 27 months. For HIV test site director boards and staff, maximum time in the study is 27 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Scaling up HIV Prevention Trials Network (HPTN) 074: a Cluster Randomized Implementation Trial of an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard Intervention Mapping (IM)
IM sites will use a standard, one-size-fits-all package of implementation strategies for SNaP implementation.
Other: Standard Intervention Mapping (IM)

The implementation strategies for IM sites will be one-size-fits-all, identified through centralized Intervention Mapping. The IM sites will be given a set package of implementation strategies for use to implement SNaP at their sites.

Before SNaP implementation starts, the specific set of one-size-fits-all implementation strategies will be determined through a formal process with investigators, government stakeholders, and clinical representatives.


Experimental: Tailored Intervention Mapping (TIM)
TIM sites will have the IM arm package of implementation strategies plus an expanded menu of implementation strategies to choose from to match their implementation strategies to site-specific barriers for SNaP implementation.
Other: Tailored Intervention Mapping (TIM)
The implementation strategies for TIM sites will be tailored to match site-specific barriers to implementation of SNaP at that site. The TIM sites will be able to choose implementation strategies from the set of implementation strategies offered in the IM arm, and in addition, the TIM sites will receive an expanded menu of implementation strategies that they can also choose from for use to implement SNaP at their sites, based on assessment of their site-specific barriers.




Primary Outcome Measures :
  1. Fidelity to SNaP Intervention Procedures [ Time Frame: 24 months after SNaP implementation ]

    Fidelity measures whether the SNaP intervention was delivered as intended.

    Fidelity score = (% Systems navigation sessions completed x Average navigation session quality score) + (% Counseling sessions completed x Average counseling session quality score)

    Session completion will be assessed by reviewing the navigator and counselor logs, while session quality will be assessed by central implementation team review and scoring of a random 10% of all forms (navigation) and audio-recordings (psychosocial counseling).

    Test site fidelity score range: 0-200 (Higher score indicates higher fidelity.)


  2. % PWID Who Initiated ART [ Time Frame: 24 months after SNaP implementation ]

    % of PWID who initiated ART among the PWID who received SNaP, measured through ART clinic records of consenting PWID.

    This measures ART uptake among PWID who received the SNaP intervention.



Secondary Outcome Measures :
  1. % PWID Who Were Contacted and Participated in SNaP [ Time Frame: 24 months after SNaP implementation ]

    Penetration of SNaP at the test sites is assessed by this measure.

    Penetration of SNaP is defined as the proportion of newly diagnosed PWID at test sites who are contacted by a navigator and/or counselor and participate in a SNaP session.


  2. Acceptability of SNaP by PWID and Test Site Staff [ Time Frame: 24 months after SNaP implementation ]

    Acceptability is the perception that the SNaP intervention is agreeable, palatable, or satisfactory to PWID and test site staff.

    Acceptability will be assessed using the Acceptability of Intervention Measure (AIM), which consists of 4 items containing responses on a 5-point Likert scale. The AIM score will be the sum of the 4 item responses.

    AIM score range: 4-20 (Higher AIM score indicates higher acceptability.)

    A separate acceptability score will be determined for PWID and for test site staff.


  3. % PWID Who Are Virally Suppressed [ Time Frame: 24 Months after SNaP implementation ]

    % of PWID who are virally suppressed among the PWID who received SNaP

    Viral suppression is defined as undetectable viral load. (This outcome will be measured only in the PWID subsample cohort.)


  4. % PWID on Medication-Assisted Treatment (MAT) [ Time Frame: 24 Months after SNaP implementation ]

    % of PWID on MAT among the PWID who received SNaP, measured through MAT clinic records of consenting PWID.

    This measures MAT uptake among PWID who received SNaP.


  5. Incremental Cost-Effectiveness Ratio of IM Compared to TIM for SNaP Implementation [ Time Frame: 24 months after SNaP implementation ]
    The incremental cost per incremental ART uptake, comparing TIM to IM, measured as: The difference in costs of implementing SNaP in TIM compared to IM sites divided by the difference in ART uptake in TIM compared to IM sites.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

PWID participants:

  1. HIV infection:

    • Newly diagnosed HIV infection, based on confirmatory test, and not currently on ART at the time of study enrollment; or
    • If previously diagnosed with HIV infection, then must not currently be on ART at the time of study enrollment (self-reported)
  2. Age 18 years or older
  3. Injection drug use within the past 6 months (self-reported at time of screening)
  4. Willing to provide informed consent for the study

Test site director boards and staff:

  1. All test site director boards and staff, including the navigators and counselors, at the selected HIV test sites
  2. Willing to provide informed consent for the study

Exclusion Criteria:

PWID participants:

  1. Residence outside of the catchment area of local antiretroviral therapy (ART) and medication-assisted treatment (MAT, e.g. methadone) clinics
  2. Currently on ART at time of study enrollment (self-reported)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952520


Contacts
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Contact: Minh XB Nguyen 443-762-6377 binhminh@live.unc.edu
Contact: Teerada Sripaipan, MPH 919-966-6236 teerada@email.unc.edu

Locations
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Vietnam
Hanoi Medical University Not yet recruiting
Hanoi, Vietnam
Contact: Thi Minh An Dao, MD    +84-912-512-189    daominhan@hmu.edu.vn   
Principal Investigator: Thi Minh An Dao, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
Ohio State University
Johns Hopkins University
Hanoi Medical University
Vietnam Administration for HIV/AIDS Control (VAAC)
Investigators
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Principal Investigator: Vivian F Go, PhD, MPH, MA University of North Carolina, Chapel Hill
Principal Investigator: William C Miller, MD, PhD, MPH Ohio State University

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03952520     History of Changes
Other Study ID Numbers: 18-2901
1R01DA047876-01 ( U.S. NIH Grant/Contract )
IGHID 11844 ( Other Identifier: UNC )
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results of an article, after de-identification.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be available 6 months to 5 years after publication of the primary outcomes paper.
Access Criteria:

Other researchers who provide a methodologically sound proposal to study investigators may be provided access to de-identified data from the study.

The other researchers must execute a Data Use Sharing Agreement with the University of North Carolina at Chapel Hill (UNC) and obtain the applicable regulatory approvals from their institution before it is permissible for study investigators to share data with the other researchers.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
Cluster randomized controlled implementation trial
Intervention mapping
People who inject drugs
HIV/AIDS
Systems navigation
Psychosocial counseling
Vietnam

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents